FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ATRISORB BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER KIT
K Number: K982865
·
Decision Sep 8, 1998
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
30
Applicant Total
3
Review Days
26
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Basic Information
- Device Name
- ATRISORB BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER KIT
- K Number
- K982865
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Atrix Laboratories, Inc.
- Date Received
- August 13, 1998
- Decision Date
- September 8, 1998
- Product Code
- NPK
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NPK | Barrier, Synthetic, Intraoral | FDA class 2 | Dental |
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